Connecting element for mounting a blood pump or a cannula on a heart

ABSTRACT

A connecting element for connecting a blood pump or a cannula to a heart, the connecting element including a sealing element, which is designed to at least temporarily close an opening formed in the cardiac wall and to be opened via insertion of a preferably cylindrical object in the direction of an axis of the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of, and claims priorityunder 35 USC §120 to, U.S. patent application Ser. No. 14/354,922,“CONNECTING ELEMENT FOR MOUNTING A BLOOD PUMP OR A CANNULA ON A HEART,”filed Apr. 28, 2014, the entire contents of which are incorporated byreference, which is a 371 nationalization of PCT/EP2012/071543, entitled“CONNECTING ELEMENT FOR MOUNTING A BLOOD PUMP OR A CANNULA ON A HEART,”having an international filing date of Oct. 31, 2012, the entirecontents of which are hereby incorporated by reference, which in turnclaims priority to German patent application 102011117892.2 filed onOct. 31, 2011, entitled “VERBINDUNGSELEMENT ZUM MONTIEREN EINERBLUTPUMPE ODER EINER KANÜLE AN EINEM HERZEN,” the entire contents ofwhich are hereby incorporated by reference.

BACKGROUND

The invention relates to a connecting element for mounting a blood pumpor a cannula on a heart, and a system for mounting such a connectingelement on the heart.

In the implantation of heart assist systems in particular, inserting aso-called inlet cannula or the inlet connecting piece of an implantableblood pump into the heart through a previously formed opening isproblematic. If the implantation will be performed without the use of aheart-lung machine, the heart continues to beat during thesemanipulations, and therefore blood can freely flow out during the periodafter the opening is formed and before the cannula/pump is inserted ifmakeshift sealing measures are not implemented (sealing using thumbpressure is common). The makeshift sealing measures must be carried outvery quickly, however. The blood loss cannot be perfectly prevented andincreases in the period between formation of the opening and insertionof the cannula.

The problem is therefore that of closing the opening in the heart afterit is formed and until the cannula/pump is inserted, thereby ensuringthat problems do not occur due to a relatively long time period betweenformation of the opening and insertion.

SUMMARY

According to the invention, a connecting element for an implantableblood pump or a cannula, which can be attached on the heart, contains asealing element, which can be opened via axial insertion of acylindrical object, for example, but which otherwise tightly closes anopening in the cardiac wall formed under the connecting element.

By way of such a preferably valve-like sealing element, an openingformed in the cardiac wall is reliably sealed for the time periodbetween formation of the opening and attachment of the blood pump orcannula. As a result, blood loss is reliably reduced independently ofthe working speed of the operating surgeon.

The connecting element can comprise a suture ring, which can be suturedwith the cardiac wall. After the blood pump or cannula is attached, thesuture ring can seal the connection between the blood pump or cannulaand the heart and hold the cannula or the blood pump against the heart.The connecting element can also be embodied as an anchoring elementhaving any other type of design.

In order to obtain the best possible sealing effect between the suturering and the pump connector, the suture ring can be made, on the innercurvature thereof, of a soft sealing material such as velour or avelour-silicone combination, for example.

The radially outward part of the suture ring can be made of a materialthat is highly resistant to mechanical deformation, such as titanium orsurgical steel, in order to prevent or limit deformability of the suturering during operation and therefore support of the sealing properties ofthe inner soft curvature against the blood pump and the cannula asdescribed above.

In addition, a connector ring can be provided, which is used to connectthe sealing element to the suture ring. The connector ring can be madeof a rigid material in order to obtain the most reliable connectionpossible to the sealing element. The connector ring can be designed tobe connected to the suture ring via bonding or suturing.

The connector ring and/or the sealing element can comprise at least onedetent element, by way of which the sealing element can be locked withthe connector ring. Alternatively or additionally, other connections,such as positive, non-positive or bonded connections, can be providedbetween the connector ring and the sealing element. For example, theconnector ring can be bonded with the sealing element. The sealingelement can also be integral with the connector ring.

In one exemplary embodiment, the sealing element comprises a pluralityof freely openable subregions (also referred to as sectors), which havea convex side and a concave side and can be flexible. The freelyopenable subregions can be designed, in particular, such that they arepressure-stable with respect to pressure on the convex side, while theycan be pressed open from the concave side. As a result, the bloodpressure that prevails in the beating heart does not cause the sealingelement to leak and even induces the sealing element to close moretightly, while the sealing element can be easily opened from the concaveside, for example via insertion of a connector and/or inflow cannula ofa blood pump.

The related sealing mechanism can be designed to be handled with onehand in order to simplify implantation using minimally invasive,sternum-sparing surgical techniques. This can be solved in adesign-related manner using a spring element, for example, which holds asealing element in the closed home position and can be moved into theopened position by the user, preferably using one hand. If the sealingelement is released after the cutting tool has been positioned and thepunch opening has been created in the cardiac wall, the sealingmechanism automatically returns to the closed home position by way ofthe restoring forces of the spring element. The surgeon therefore hashis hands free to install the pump, and the surgical site is blood-free.

Alternatively, the sealing mechanism comprising the spring element canbe actively opened simply by inserting the punching tool and/or the pumpinflow cannula.

It should also be noted that it is not necessary for the sealing elementto be handled directly by a user using one hand; instead, it is alsopossible (in the case of deeper surgical sites) for the user to workoutside the body using a further auxiliary element for extension if thespatial conditions prevent work from being performed entirely by thehuman hand.

In one embodiment, the sealing element comprises a plurality of filmlayers. Each of the film layers can comprise two films, which are incontact with one another along one edge. The edges of adjacent filmlayers can extend at an angle relative to one another, and thereforeblood emerging from the heart along one edge of a first film layer isheld back by the next film layer. Basically, the number of film layerscan be freely selected. A larger number of film layers results in animproved sealing effect, although this makes it difficult tosubsequently open the sealing element via insertion of a cannula or aconnector of a blood pump. The use of two film layers has proven to be aparticularly suitable compromise between sealing effect and flexibility.The film layers can be incorporated or incorporable in the connectorring, for example.

In addition to the connecting element, the invention relates to a systemfor attaching a connecting element on a heart. The system comprises aconnecting element of the previously described type and a tool forpunching an opening in the heart. The tool comprises a first componentand a blade. The first component and the blade are displaceable in thelongitudinal direction of the tool relative to one another and relativeto the rest of the tool. The sealing element and the tool are designedsuch that the sealing element can be disposed in a front region of thetool. The sealing element can be slid upward via displacement of thefirst component, which can be embodied as a blade guard, for example.Next, the blade can be slid through the sealing element without damagingit.

In addition to the first component and the blade, the tool can alsocomprise a sliding element. This can be a contact surface for thesealing element. The sliding element can be displaceable in thelongitudinal direction of the tool, thereby permitting the sealingelement to be pushed into the connector ring using the sliding element.This is particularly advantageous when the sealing element and/or theconnector ring comprise a detent element and can be locked to oneanother.

BRIEF DESCRIPTION OF DRAWINGS

Exemplary embodiments of the connecting element and the system areexplained in greater detail with reference to the figures and aredescribed in terms of functionality. Shown are:

FIG. 1 shows a sectional view of a suture ring attached to a cardiacwall, comprising a connector ring mounted thereon,

FIG. 2 shows a perspective view of a tool for forming openings inhearts, at an angle from the front,

FIG. 3 shows the tool depicted in FIG. 2 with the blade slid forward,

FIG. 4 shows a sectional view and a perspective view of an embodiment ofa sealing element,

FIG. 5 shows the tool depicted in FIG. 3 having the sealing elementdepicted in FIG. 4 mounted thereon,

FIG. 6 shows the tool depicted in FIG. 3 having the sealing elementdepicted in FIG. 4 mounted thereon, in a sectional view before theopening is formed in the cardiac wall,

FIG. 7 shows the tool depicted in FIG. 3 having the sealing elementdepicted in FIG. 4 mounted thereon, in a sectional view while theopening is being formed in the cardiac wall,

FIG. 8 shows the tool depicted in FIG. 3 having the sealing elementdepicted in FIG. 4 mounted thereon, in a sectional view after theopening is formed in the cardiac wall and before the sealing elementbecomes locked,

FIG. 9 shows the tool depicted in FIG. 3 having the sealing elementdepicted in FIG. 4 mounted thereon, in a sectional view after theopening is formed in the cardiac wall and after the sealing element islocked,

FIG. 10 shows a sectional view of the locked sealing element depicted inFIG. 4,

FIG. 11 shows a sectional view of the locked sealing element depicted inFIG. 4 as a pump or cannula is inserted,

FIG. 12 shows a back view, a sectional view and a front view of analternative embodiment of a sealing element.

DETAILED DESCRIPTION

As shown in FIG. 1, a suture ring 5 a, which is made of a soft sealingmaterial such as velour or a velour-silicone combination, for example,is sutured to the heart H using thread F before the opening is formed.The purpose of the suture ring is to hold the cannula/pump against theheart and seal the heart and the pump with respect to one another.

The suture ring is fixedly connected to a rigid connector ring 5,wherein the connection can be in the form of an adhesive connectionand/or a seam.

To ensure clarity, the illustrations that follow only show the connectorring and not the suture ring.

A special tool, which is shown in FIG. 2, is used to form an opening inthe heart. This comprises a blade guard 2, the blade 4 and a slidingelement 3. The parts can move axially (i.e. in the direction a) relativeto one another. The blade guard has a central opening for the routingtherethrough of a thread, for example, or any other type of aid forcaptively holding the slug produced when the opening is formed. Inparticular, the blade can be slid forward past the blade guard, as shownin FIG. 3, thereby cutting an opening in the heart by way of the bladeedge 4 a.

A valve ring 1 made of soft elastic material (silicone, in particular)can be placed onto this tool. This comprises, for example, at leastthree freely openable and deformable sectors 1 a, which are formed viaslits in the ring. In FIG. 4, the valve ring 1 is shown having foursectors 1 a, although only three sectors or more than four sectors couldbe provided. The valve ring is further equipped with the collar 1 b andthe collar 1 c and a sealing lip 1 d. When the sectors are not foldedopen and are undeformed, they form a dome, which is pressure-stable andimpenetrable (in accordance with the requirements) on the convex side.Instead of a dome, it is also possible to use so-called tricuspid flaps,which are used in artificial heart valves.

The sectors of the valve ring can be pressed open and deformed by way ofthe blade guard (with the blade retracted), as shown in FIG. 5.

The tool, with the valve ring fully folded open, is inserted into theconnector ring (which is connected to the not-shown suture ring). Athread F, which was previously sewn through the heart, is routed throughthe bore 2 a of the blade guard, as shown in FIG. 6.

When the blade is slid forward, the slug HB is cut out of the cardiacwall, wherein the slug is held steady by pulling on the thread. FIG. 7shows the tool comprising the sealing element at this point of use.

The blade, the slug (with thread) and the blade guard can be retracted,wherein a brief (acceptable) leak forms through the gap between thevalve ring sectors and the connector ring. The tool comprising thesealing element is shown in FIG. 8 at this point of retraction.

The valve ring 1 can be slid into the connector ring 5 using the slidingelement 3, wherein the collars 1 b and 1 c fix the position. The sectorsof the valve ring close and seal the opening in the heart. The sealintegrity with respect to the tool is maintained since the slug restsagainst the blade. This situation is depicted in FIG. 9. The closedsealing element is shown in FIG. 10. The tool can now be removed.

When the pump/cannula 6 is inserted, the sectors of the valve ring areopened once more. The pump is connected to the connector ring via means,which are not shown. The pump is sealed with respect to the connectorring at the sealing lip 1 d of the valve ring. The sealing element, withpump/cannula inserted, is shown in FIG. 11.

To prevent the sectors of the valve ring from lying against the walls ofthe opening in the heart, the connector ring can be designed to behigher, thereby enabling the sectors to fold open within the connectorring.

Another way to implement a suture ring valve is to equip the connectorring with, for example, four tensioned films (8 a, 8 b, 9 a, 9 b) madeof thin elastic material (e.g. silicone), the adjoining edges BK ofwhich extend radially, wherein two edges are offset by 90° in each case.Such an exemplary embodiment of a sealing element is shown in FIG. 12.

The films are fastened to the connector ring using a clamping ring 7.When a rounded cylindrical object (the aforementioned tool orpump/cannula) is inserted axially, the films are stretched, andtherefore the adjoining edges thereof deform, expand and lie closelyagainst the cylindrical surface of the object inserted through theslits.

According to a further aspect of the invention, a connecting element foran implantable blood pump or a cannula, which is attached at the heart(as usual), contains a sealing element, which can be opened via axialinsertion of a cylindrical object, but which otherwise tightly closes anopening in the cardiac wall formed under the connecting element.

The sealing element shown in FIG. 12 therefore comprises a passagechannel and self-closing closing elements in the form of the tensionedfilms 8 a, 8 b, 9 a and 9 b. The sealing element shown there can beopened by inserting an object (e.g. the pump/cannula 6) into the passagechannel completely or at least partially, thereby establishing a fluidconnection between opposite ends of the passage channel. FIG. 11 furthershows that the opposite ends of the passage channel formed by thesealing element are aligned in the opened state of the sealing element.

The sealing element in FIG. 4 also comprises a passage channel andclosing elements for the repeated opening and closing of the passagechannel, wherein the closing elements can be formed by the sectors 1 a,which are fixedly connected to the valve ring 1. In the arrangement ofthe sealing element shown in FIG. 10, a pressure difference ofapproximately 100 mbar, for example, exists between the ventricle (atthe top in FIG. 10) and the outer side of the heart where the sealingelement is attached on the cardiac muscle, thereby forcing the sectors 1a into a closed position and closing the passage channel.

We claim:
 1. A connecting element for connecting a blood pump or acannula to a heart, comprising: a sealing element designed to at leasttemporarily close an opening formed in a cardiac wall of the heart andto be opened via insertion of a preferably cylindrical object in thedirection of an axis of the opening, and comprising an anchoring elementfor permanent attachment of the connecting element on a cardiac muscleof the heart, wherein the sealing element comprises a plurality of filmlayers, each of which has two films, which adjoin one another alongedges.
 2. The connecting element of claim 1 further comprising a suturering to be sutured with the heart.
 3. The connecting element of claim 1further comprising a connector ring for connection to the suture ringand/or the heart.
 4. The connecting element of claim 3, wherein thesealing element and/or the connector ring comprise at least one detentelement, wherein the sealing element can be locked with the connectorring by way of the detent element.
 5. The connecting element of claim 1,wherein the sealing element comprises a passage channel and at least oneself-closing closing element for the repeated opening and closing of thepassage channel, wherein the closing element is designed to be openedvia insertion of an object into the passage channel.
 6. The connectingelement of claim 1, wherein the sealing element comprises a passagechannel and at least one closing element for the repeated opening andclosing of the passage channel, wherein the at least one closing elementis designed to close the passage channel when a pressure differenceexists along a specified direction of the passage channel.
 7. Theconnecting element of claim 5 or 6, wherein the at least one closingelement is formed by the plurality of film layers.
 8. The connectingelement of claim 1, wherein the sealing element comprises a plurality offreely openable subregions, which have a convex side and a concave sidesuch that the sealing element remains closed when pressure is appliedfrom the direction of the convex side and opens when pressure is appliedfrom the direction of the concave side.
 9. The connecting element ofclaim 1, wherein the edges of various film layers extend at an anglerelative to one another.
 10. The connecting element of claim 1, whereinthe edges of various film layers extend at a right angle relative to oneanother.
 11. The connecting element of claim 1, wherein the edges ofvarious film layers extend radially.
 12. The connecting element of claim1, wherein the sealing element comprises exactly two of said filmlayers.
 13. The connecting element of claim 1, wherein the sealingelement comprises more than two of said film layers.
 14. The connectingelement of claim 3, wherein the film layers are incorporated in theconnector ring.
 15. The connecting element of claim 14, wherein thefilms are fastened to the connector ring using a clamping ring.
 16. Theconnecting element of claim 1, wherein the films of the film layers aretensioned.
 17. The connecting element of claim 1, wherein the filmlayers are self-closing.
 18. The connecting element of claim 1, whereineach one of the film layers is self-closing.
 19. The connecting elementof claim 1, wherein the films of the film layers are made of thinelastic material.
 20. The connecting element of claim 1, wherein thefilms of the film layers are made of silicone.
 21. A system comprising:a connecting element comprising a sealing element configured to at leasttemporarily close an opening formed in a cardiac wall of a heart, thesealing element further configured to be opened via insertion of acylindrical object in a direction of an axis of the opening, theconnecting element further comprising an anchoring element forattachment of the connecting element to a cardiac muscle of the heart,wherein the sealing element comprises a plurality of film layers, eachof which has two films, which adjoin one another along edges; and a toolfor forming the opening in the heart, wherein the tool for forming theopening in the heart comprises a first component and at least one blade,which are displaceable in a longitudinal direction of the tool relativeto one another and relative to the rest of the tool, and wherein atleast the sealing element of the connecting element is disposable in afront region of the tool for forming an opening in the heart, in such away that the sealing element of the connecting element is opened whenpressed by the first component of the tool and, subsequently, permitsthe blade of the tool for forming the opening in the heart to passthrough the sealing element.
 22. The system of claim 21, wherein thefirst component is designed as a blade guard.
 23. The system of claim21, wherein the tool for forming an opening in the heart comprises asliding element, which forms a contact surface for the sealing elementand is displaceable in the longitudinal direction of the tool in orderto push the sealing element into the connector ring.